Actively Recruiting
Comparison of Remimazolam Versus Propofol-based General Anesthesia on Postoperative Quality of Recovery in Patients Undergoing Ambulatory Upper Airway Surgery: a Randomized Controlled Trial
Led by Chung-Ang University Gwangmyeong Hospital · Updated on 2024-07-18
116
Participants Needed
1
Research Sites
8 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to compare the effects of remimazolam and propofol on recovery time, complications, and safety in adult patients undergoing ambulatory upper airway surgery under general anesthesia. The trial focuses on surgeries involving the nasal cavity, oral cavity, pharynx, and larynx, evaluating which anesthesia method may influence postoperative recovery quality. Participants are randomly assigned to either the Remimazolam group or the Propofol group. In the Remimazolam group, anesthesia is started and maintained by continuous infusion of remimazolam and remifentanil, with recovery supported by flumazenil. In the Propofol group, anesthesia uses continuous infusion of propofol and remifentanil via target concentration controlled infusion. Both groups receive rocuronium for muscle relaxation and sugammadex to reverse this effect after surgery. During the study, recovery times and adverse events are recorded at three stages: in the operating room, in the post-anesthesia care unit (PACU), and in the day surgery center. Assessments include eye opening time, extubation time, PACU transfer time, stay durations, pain scores, alertness levels, and safety monitoring over several hours following surgery. The primary outcome is the time until patients are fit for discharge, measured 15 minutes after surgery.
CONDITIONS
Brief Title
Comparison of Remimazolam and Propofol for Recovery of Ambulatory Upper Airway Surgery
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adult patients age 19 or older undergoing ambulatory upper airway (nasal cavity, oral cavity, pharynx, larynx) surgery under general anesthesia
- Physical health classified as American Society of Anesthesiologists physical class I, II, or III
You will not qualify if you...
- Patients who refuse to participate in the study
- Pregnant patients
- History of hypersensitivity to drugs or additives used during surgery
- Patients with acute narrow-angle glaucoma
- Alcohol or drug dependent patients
- Patients with Child-Pugh class C liver dysfunction
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Surgery day
Participants undergo ambulatory upper airway surgery under general anesthesia using either remimazolam or propofol, with additional medications for neuromuscular blockade and reversal.
1 surgical visit (in-person)
Duration - Up to 6 hours after surgery
Participants are monitored for recovery time, adverse events, and anesthesia recovery indicators in the operating room, post-anesthesia care unit, and day surgery center.
Continuous monitoring during recovery period
Trial Site Locations
Total: 1 location
1
ChungAng University Gwangmyeong Hospital
Gyeonggi-do, Gwangmyeon-si, South Korea, 14353
Actively Recruiting
Research Team
S
Se-Hee Min
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here